title: Summary of confirmation cut point discussions.
abstract: A subgroup of AAPS NBC Immunogenicity Workshop attendees met to discuss the current recommendations in white papers and guidance documents, to describe and discuss current practices, and to resolve concerns as to the biologically and statistically appropriate approaches to determining a confirmatory cut point for immunogenicity assays. This is a summary of our discussions and recommendations.
authors.affiliation: Investigative Toxicology, Eli Lilly and Company, Indianapolis, Indiana 46285, USA.
authors.forename: Holly W
authors.initials: HW
authors.lastname: Smith
authors.forename: Michael
authors.initials: M
authors.lastname: Moxness
authors.forename: Robin
authors.initials: R
authors.lastname: Marsden
mesh_terms: D000906:Antibodies / Q000276:immunology; D001688:Biological Products / Q000276:immunology*; D003627:Data Interpretation, Statistical; D004345:Drug Industry / Q000379:methods*; D007118:Immunoassay / Q000379:methods*
chemical_list: D000906:Antibodies; D001688:Biological Products